Status:
COMPLETED
Nonalcoholic Fatty Liver Disease - Intermittent Calorie Restriction (FLICR) Study
Lead Sponsor:
Ewha Womans University Mokdong Hospital
Conditions:
Nonalcoholic Fatty Liver
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
19-75 years
Phase:
NA
Brief Summary
Several diets have been proposed to reduce liver steatosis in patients with nonalcoholic fatty liver disease (NAFLD), and various effects on liver steatosis have been observed. The objective of this t...
Detailed Description
This is an open-label randomised controlled trial of patients with NAFLD. Patients are recruited in the Liver Outpatient Clinic of the Ewha Womans University Mokdong Hospital. The department of Nutrit...
Eligibility Criteria
Inclusion
- NAFLD diagnosed by (1) Histologic assessment with a fat accumulation of more than 5% of the liver's weight in a biopsy, or (2) Radiologic assessment with a MRI-PDFF ≥8%.
- Age between 19 and 75 years
- Capability to understand the study and the individual consequences of participation
- Signed and dated declaration of agreement in the forefront of the study
Exclusion
- Daily alcohol consumption \>30 g in men and \>20 g in women
- Other causes of chronic liver disease (HBV, HCV, HDV, HEV, HIV), autoimmune diseases or chronic cholestatic liver disease, drug induced liver injury, hereditary haemochromatosis, Wilson disease, α-1-Antitrypsin deficiency
- Liver cirrhosis
- Hepatocellular carcinoma
- Medications which cause liver disease or secondary NAFLD (e.g. Tamoxifen, systemic Corticosteroids, Methotrexate, Tetracycline, Estrogens, Valproic acid)
- Changes in body weight \> 5% in the last 3 months
- Intake of medical treatment for NAFLD/NASH in the last 6 months (except for vitamin E)
- Diabetes
- Pregnancy
- Patients after organ transplantations
- Missing or lacking consent capability
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05309642
Start Date
March 7 2022
End Date
December 6 2023
Last Update
February 20 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ewha Womans University College of Medicine
Seoul, Yangcheon-gu, South Korea, 07985